Pharmaceutical Technology - September 2019

Pharmaceutical Technology - Regulatory Sourcebook

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Page 42 of 54

Pharmaceutical Technology REGULATORY SOURCEBOOK SEPTEMBER 2019 43 Pharmacopoeia Compliance Series T his series of articles continues to take a thorough look at compendial activities that impact the bio/ pharmaceutical industry to help ensure compliance with requirements published by the pharmacopoe- ias. In these articles, the term "bio/pharmaceutical" should be considered in the broadest sense and includes innovator, generic, virtual, and start-up companies who discover, de- velop, manufacture, and/or distribute small-molecule drug products, biotherapeutic products, and vaccines, as well as the drug substances and excipients used in these products. One aspect of the history of the pharmacopoeias should be apparent; there is a long-standing tradition of evalu- ating existing, divergent drug standards and establishing instead a unified system that supports patient access to medicines with consistent quality. This is true whether the divergent standards existed at the city-level, as were ad- dressed through the creation of the country-specific Brit- ish Pharmacopoeia (BP), or if the existing standards were at the state-level, as were addressed through the creation of the United States Pharmacopeia (USP). This is also true at a regional level, as in the creation of the European Phar- macopoeia (Ph. Eur.), which established harmonized stan- dards for medicines in Europe where individual country- specific standards had previously existed. And this is true in the initial intention of the International Pharmacopoeia (Ph. Int.) to develop a unified pharmacopoeia that could be used around the world. In this context, it may be suggested that harmoniza- tion is embedded in the development and history of the pharmacopoeias. However, the pharmacopoeias are them- selves embedded within the current regulatory and legal framework of the countr y or region in which they are applicable. The intersection of the pharmacopoeias and regulatory agencies impacts the direction and approaches taken to move toward harmonization at a global level. Pharmacopoeia harmonization provides better support for global regulatory agencies and addresses the global nature of bio/pharmaceutical manufacturing and supply, which ultimately benefits global patients who rely on these medicines to extend and improve their lives. This article provides some industry perspective on the need to har- monize compendial standards, which may be helpful in considering the future direction of pharmacopoeias. These Global Pharmacopoeia Standards: Why Harmonization is Needed J. Mark Wiggins and Joseph A. Albanese In this series of articles, the authors provide an understanding about the need for pharmacopoeia compliance and practical guidance to assist those who perform this work. The following articles can be found within this ebook and online at • Why Pharmacopoeia Compliance Is Necessary • Why Pharmacopoeia Compliance Is Difficult • A Brief History of Pharmacopoeias: A Global Perspective • Global Pharmacopoeia Standards: Why Harmonization is Needed • Harmonization Efforts by Pharmacopoeias and Regulatory Agencies Upcoming articles in this series will include the following: • Revision Process for Global/National Pharmacopoeias • Surveillance Process for Industry: Monitoring Pharmacopoeia Revisions • Monograph Development: Why and When to Participate • Monograph Development: How to Participate; How to Harmonize • A Practical Approach to Pharmacopoeia Compliance • A Case Study in Pharmacopoeia Compliance: Excipients and Raw Materials • Pharmacopoeia Compliance: Putting it All Together; What is on the Horizon J. Mark Wiggins is owner and compendial consultant with Global Pharmacopoeia Solutions LLC. Joseph A. Albanese is the director of Analytical Strategy and Compliance at Janssen Research and Development, LLC.

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